BCS II waiver approach [Dissolution / BCS / IVIVC]
Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.
In the above scenario, can we consider for BCS based waiver approach ?
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